RESUSCITATION UNIT 105

K103317 · Atom Medical Corporation · BZR · Apr 20, 2011 · Anesthesiology

Device Facts

• Record ID: K103317
• Device Name: RESUSCITATION UNIT 105
• Applicant: Atom Medical Corporation
• Product Code: BZR · Anesthesiology
• Decision Date: Apr 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5330
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Resuscitation Unit 105 PV and Resuscitation Unit 105 EV are intended to remove secretions from the neonatal / infant airways and to provide blended air and oxygen at a desired oxygen concentration in the range of 21-100% to a respiratory assist device connected to the patient such as a ventilator (including a manually operated one) and an oxygen tent.

Device Story

Resuscitation Unit 105 (models 105PV and 105EV) provides blended air/oxygen and suction for neonates/infants. Inputs: compressed air and oxygen; 105PV uses wall vacuum, 105EV uses internal venturi. Operation: manual blending of gases; pressure regulation via relief valve; monitoring via integral pressure gauge. Output: blended gas mixture to respiratory devices (tents, masks, ventilators) and suction for airway clearance. Used in NICU/delivery suites by trained clinicians. Output allows clinicians to manage oxygen concentration and airway pressure; benefits include improved respiratory support and secretion management.

Clinical Evidence

Bench testing only. Testing included flow accuracy, pressure gauge accuracy, O2 concentration (ISO 10651-5), and suction performance (ISO 10079-3: overfill, seal, aspiration, pressure, noise). Results demonstrated device performance met all pass/fail criteria and was equivalent to predicate devices.

Technological Characteristics

Gas-powered blender and suction unit. Features: pressure relief valve, pressure gauge, suction pressure gauge, dual outlets. 105PV: wall vacuum; 105EV: venturi vacuum. Gas sources: compressed air/oxygen (206-517 kPa). Blender range: 21-100% O2 (±3%). Flow rate: <15 lpm. Standards: ISO 10651-5 (resuscitators), ISO 10079-3 (suction). Mechanical/pneumatic operation; no software/electronics described.

Indications for Use

Indicated for neonates and infants requiring airway secretion removal or delivery of blended air/oxygen (21-100%) to respiratory assist devices (ventilators, oxygen tents, masks, cannulas). Prescription use only in hospitals, delivery suites, and NICUs.

Regulatory Classification

Identification

A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.

Predicate Devices

• Atom V-505 Infant Warmer (K060461)
• Bio-Med Devices BMD air/oxygen blender (K925982)
• Precision Medical Precision Blender (K053232)
• GE Giraffe and Panda system (K070210)

Submission Summary (Full Text)

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.K103317

## 510(k) Summary Page 1 of 8 5-Apr-11

APR 2 0 2011

| Atom Medical Corporation<br>3-18-15, Hongo, Bunkyo-ku<br>Tokyo, Japan 113-0033 | Tel - 011-81-3-3815-3632<br>Fax - 011-81-3-3812-3199 |
|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Tsuyoshi Sugino - Regulatory Affairs Manager |
| Proprietary or Trade Name: | Resuscitation Unit 105 |
| Common/Usual Name: | Air / oxygen blender |
| Classification Name/Code: | BZR - Breathing gas mixer<br>CFR 868.5330 |
| Device: | Resuscitation Unit 105EV<br>Resuscitation Unit 105PV |
| Predicate Devices: | Bio-Med Devices_BMD_air/oxygen_blender_K925982<br>Precision Medical - Precision Blender - K053232<br>Atom Medical - V-505 Infant Warmer - K060461<br>GE Giraffe and Panda system - K070210 |

## Device Description:

There are two (2) models of the Resuscitation Unit 105 air / oxygen blender with suction.

- Resuscitation Unit 105PV .
- . Resuscitation Unit 105EV

They have the same basic design. Table 1 outlines the basic features and differences of each model.

## Indications for Use:

The Resuscitation Unit 105 EV and Resuscitation Unit 105 PV are intended to remove secretions from the neonatal / infant airways and / or to provide blended air and oxygen at a desired oxygen concentration in the range of 21-100% to a respiratory assist device connected to the patient such as a ventilator (including a manually operated one) and an oxygen tent.

Environment of Use: Hospitals, delivery suites, NICU

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## 510(k) Summary Page 2 of 8 5-Apr-11

## Table 1 Resuscitation Models 105PV and 105EV

| Feature | Resuscitation Unit 105PV | Resuscitation Unit 105EV |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Suction(Piping Type) | Yes | No |
| Suction(Venturi Type) | No | Yes |
| Oxygen / Air Blender | Yes | Yes |
| Inlet Gas Sources | Oxygen compressed gas | Oxygen compressed gas |
| | Air compressed gas | Air compressed gas |
| | Suction compressed gas | |
| Pressure Relief Valve | Yes | Yes |
| Pressure Gauge | Yes | Yes |
| Suction Pressure Gauge | Yes | Yes |
| Outlet | Double outlets<br>(Outlet A/B) | Double outlets<br>(Outlet A/B) |
| | Outlet A / B is for delivery of the air/oxygen gas mixture to a<br>variety of devices, i.e., oxygen tent, oxygen mask, nasal cannula,<br>manual resuscitator or manual ventilator, in-line humidifier jar,<br>etc. | |
| | Airway Pressure tube and adapter can be connected at the patient<br>connected to measure and monitor the airway pressure which is<br>displayed on the integral pressure gauge as well as a pressure<br>regulating valve | |

As outlined in Table 1, the Resuscitation Unit 105 EV and Resuscitation Unit 105 PV are identical except for the source for vacuum. Model 105PV is from a wall vacuum source and Model 105EV is from an internal venturi.

Table 2 compares the Resuscitation Unit 105 EV and Resuscitation Unit 105 PV to the predicates:

- Atom V-505 Infant warmer with optional oxygen / suction module (K060461) .
- . Bio-Med Devices – BMD air/oxygen blender (K925982) a blender which is incorporated into the proposed devices
- . Precision Medical – Precision Blender (K053232) which has the indications for use and product classification we are seeking.

Table 3 compares the Resuscitation Unit 105 EV and Resuscitation Unit 105 PV to the predicates Atom V-505 Infant warmer with optional oxygen / suction module (K060461) and the GE Giraffe and Panda system (K070210) which incorporates suction function and features for the intended patient population and environment.

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510((k) Summary

S-Apr-11

# able of the Similarities and Differences to the Predicates for Air / Oxygen Blender feature

| General Attributes | Resuscitation Unit<br>Unit 105PV<br>Unit 105EV | Atom V-505 Infant<br>Warmer with oxygen /<br>suction module K060461 | Bio-Med Devices<br>BMD air/oxygen<br>blender K925982 | Precision Medical<br>Precision Blender<br>K053232 | |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Indications for Use | The Resuscitation Unit<br>105 EV and<br>Resuscitation Unit 105<br>PV are intended to remove<br>secretions from the<br>neonatal / infant airways or<br>to provide blended air and<br>oxygen at a desired oxygen<br>concentration in the range<br>of 21-100% to a respiratory<br>assist device connected to<br>the patient such as a<br>ventilator (including a<br>manually operated one)<br>and an oxygen tent. | The blender and suction<br>modules incorporated in the<br>V-505 Infant Warmer are<br>intended to remove<br>secretions from the neonatal<br>/ infant airways or to<br>provide blended air and<br>oxygen at a desired oxygen<br>concentration in the range of<br>21-100% to a respiratory<br>assist device connected to<br>the patient such as a<br>ventilator (including a<br>manually operated one) and<br>an oxygen tent. | There is no indications<br>for sue statement in the<br>FDA database but the<br>BMD air/oxygen<br>blender is intended to<br>provide blended air and<br>oxygen at a desired<br>oxygen concentration in<br>the range of 21-100% | Is intended to deliver<br>blended air and oxygen in<br>a hospital setting.<br>Oxygen concentrations<br>can be dialed in from 21<br>to 100%. The blender is<br>not intended as a life<br>supporting device. | |
| Patient Population | Neonates and Infants | Neonates and Infants | Not specified | Not specified | |
| Environment of Use | Hospital, delivery suites,<br>NICU | Hospital, delivery suites,<br>NICU | Hospital, delivery<br>suites, NICU | Hospital setting | |
| Prescriptive | Yes | Yes | Yes | Yes | |
| | | Page 4 of 8<br>5-Apr-11 | | | |
| | Resuscitation Unit<br>Unit 105PV<br>Unit 105EV | Atom V-505 Infant<br>Warmer with oxygen /<br>suction module K0604618 | Bio-Med Devices<br>BMD air/oxygen<br>blender K925982 | Precision Medical<br>Precision Blender<br>K053232 | |
| General Attributes (continued) | Outlet connections to | Oxygen tent<br>Oxygen mask<br>Cannula<br>Manual ventilator<br>Manual resuscitator | Oxygen tent<br>Oxygen mask<br>Cannula<br>Manual ventilator<br>Manual resuscitator | Oxygen tent<br>Oxygen mask<br>Cannula<br>Manual ventilator<br>Manual resuscitator<br>None supplied | Oxygen tent<br>Oxygen mask<br>Cannula<br>Manual ventilator<br>Manual resuscitator<br>None supplied |
| | Accessories/Components | Airway pressure tube<br>Hoses and tubing<br>Humidifier jar<br>Suction jar | Hoses and tubing<br>Humidifier jar<br>Suction jar | | |
| Technical specifications | Oxygen / air supply module | | | | |
| | Gas sources | Air/O₂<br>300-500kPa | Air/O₂<br>206-517kPa | Air/O₂<br>206-517kPa | Air/O₂<br>206-517kPa |
| | input pressure | | | | |
| | Airway pressure<br>manometer<br>Range Accuracy | -20 to 80cmH₂O<br>±1% of full scale | N/A | N/A | N/A |
| | Air/O₂ blender<br>Range<br>Accuracy | | 21-100%<br>±3%O₂ | 21-100%<br>±3%O₂ | 21-100%<br>±3%O₂ |
| | Alarm | | Differential pressure<br>between oxygen and air<br>supply | Differential pressure<br>between oxygen and air<br>supply | Differential pressure<br>between oxygen and air<br>supply |
| | Bleed flow rate | | 2.5-3.5 lpm | N/A | N/A |
| | Gas flow rate range | < 15 lpm | < 15 lpm | ≥ 30 lpm | ≥ 30 lpm |
| | | 510(k) Summary<br>5 of 8<br>5-Apr-11 | | | |
| | Resuscitation Unit<br>Unit 105PV<br>Unit 105EV | Atom V-505 Infant<br>Warmer with oxygen /<br>suction module K060461 | Bio-Med Devices<br>BMD air/oxygen<br>blender K925982 | Precision Medical<br>Precision Blender<br>K053232 | |
| Technical specifications (continued) | | | | | |
| Relieving valve<br>(for preventing excessive<br>airway pressure) | (Default setting : 5.9kPa<br>(60cmH2O)) | N/A (no reliving valve) | N/A(no relieving valve) | N/A(no relieving valve) | |
| Flow outlet | Dual flow outlet to connect to<br>a device requiring a gas<br>supply<br>Oxygen density of both is the<br>same. | Single flow outlet to connect<br>to device requiring a gas<br>supply | Flow outlet for<br>connecting to device<br>requiring a gas supply | Flow outlet for connecting<br>to device requiring a gas<br>supply | |
| Standards | | | | | |
| ISO 10651-5 Gas<br>powered resuscitators | Yes, applicable sections | N/A | N/A | N/A | |
| ISO 10079-3 suction<br>equipment | Yes, applicable sections | N/A | N/A | N/A | |
| Section 514 | None | None | None | None | |

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510(k) Summary

## able of the Similarities and Differences to the Predicates for Suction features

| General Attributes | | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Indications for Use | Resuscitation Unit<br>Unit 105PV<br>Unit 105EV | Atom V-505 Infant Warmer with<br>oxygen / suction module<br>K060461 | GE<br>Giraffe and Panda<br>K070210 | |
| | The Resuscitation Unit 105 EV<br>and Resuscitation Unit 105 PV are<br>intended to remove secretions from<br>the neonatal / infant airways and to<br>provide blended air and oxygen at a<br>desired oxygen concentration in the<br>range of 21-100% to a respiratory<br>assist device connected to the patient<br>such as a ventilator (including a<br>manually operated one) and an<br>oxygen tent. | The blender and suction modules<br>incorporated in the V-505 Infant<br>Warmer are intended to remove<br>secretions from the neonatal / infant<br>airways and to provide blended air<br>and oxygen at a desired oxygen<br>concentration in the range of 21-<br>100% to a respiratory assist device<br>connected to the patient such as a<br>ventilator (including a manually<br>operated one) and an oxygen tent. | Provides the basic equipment<br>required for pulmonary<br>resuscitation of infants.<br>Pulmonary resuscitation includes<br>practices necessary to establish a<br>clear airway and provide oxygen<br>and air/oxygen mixtures and/or<br>manual ventilation to the infant.<br>(Includes a suction function and<br>feature) | |
| Patient Population | Neonates and Infants | Neonates and Infants | Infant | |
| Environment of Use | Hospital, delivery suites, NICU | Hospital, delivery suites, NICU | Hospital, delivery suites, NICU | |
| Prescriptive | Persons trained in infant / neonate<br>resuscitation | Persons trained in infant / neonate<br>resuscitation | Persons trained in infant / neonate<br>resuscitation | |
| Technical specifications | | | | |
| Suction bottle capacity | Up to 1200 ml | Not specified | Not specified other than various<br>sizes | |
| Dimensions | 200mm(W)x180 mm(D)x370mm (H) | Built-in to warmer, not standalone | 340mm(W)x250mm(D)x250mm(H) | |
| Weight | 7kg | | 9 kg | |
| Operating and Storage<br>limits | -20°C to 65°C<br>Up to 97% RH | -20°C to 65°C<br>Up to 97% RH | -20°C to 60°C<br>Up to 95% RH | |
| 510(k) Summary<br>Page 7 of 8<br>5-Apr-11 | | | | |
| | Resuscitation Unit<br>Unit 105PV<br>Unit 105EV | Atom V-505 Infant Warmer with<br>oxygen / suction module K060461 | | GE<br>Giraffe and Panda K070210 |
| Technical specifications (continued) | | | | |
| | Vacuum source | Model 105PV - wall suction<br>vacuum | Model 105PV - wall suction<br>vacuum | Wall suction<br>vacuum |
| | Vacuum range | Model 105EV - venturi method<br>0-200 mmHg | 0-200 mmHg | 0-150 mmHg |
| | Vacuum Flow range | ~ 20 lpm | N/A | 15 lpm |
| | Standards | | | |
| | ISO 10651-5 Gas<br>powered resuscitators | Yes, applicable sections | N/A | Yes, applicable sections |
| | ISO 10079-3 - Suction<br>equipment | Yes, applicable sections | N/A | Yes, applicable sections |
| | Section 514 | None | None | None |
| Summary of substantial equivalence - Resuscitation Unit 105PV and Resuscitation Unit 105EV | | | | |
| Indications for Use - The Resuscitation Unit 105 EV and Resuscitation Unit 105 PV have equivalent indications for use to the predicates. That<br>is as a breathing gas mixer (blender) with a suction feature. | | | |…